Reported Dec 11, 2024 · Ongoing
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC…
Aurobindo Pharma USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aurobindo Pharma USA Inc · 279 Princeton Hightstown Rd · East Windsor, NJ · 08520-1401
Is this the product you have?
- Cinacalcet Tablets, 30 mg
- packaged in
a) 30-count HDPE bottle (NDC 65862-831-30)b) 500-count HDPE bottle (NDC 65862-831-05)Rx Only
- Distributed byAurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India
- Lot codes and dates
Lot #: a) CFSA23001ACFSA23002ACFSA23003AExp 03/31/2025CFSA23004AExp 07/31/2025CFSA23005AExp 10/31/2025b) P2300191P2300192P2300193P2300194Exp 12/31/2024
- Amount recalled
- 102576 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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